COVER

SPECIAL FEATURE - Bioavailability & Solubility: Experimental Techniques Combined With Computational Decision-Making Rapidly ID the Most Viable Enhancement Pathway

Contributor Cindy H. Dubin highlights other ways formulators are relying on automation, such as Artificial Intelligence and Machine Learning, and how these tools are being combined with experimental confirmation to identify the most promising development strategies.

FEATURES

SPECIAL FEATURE - Bioavailability & Solubility: Experimental Techniques Combined With Computational Decision-Making Rapidly ID the Most Viable Enhancement Pathway

Contributor Cindy H. Dubin highlights other ways formulators are relying on automation, such as Artificial Intelligence and Machine Learning, and how these tools are being combined with experimental confirmation to identify the most promising development strategies.

ARTIFICIAL INTELLIGENCE - The AI-Driven Path to Precision Therapeutics

Rotem Gura-Sadovsky, PhD, and Maayan Eilon-Ashkenazy, PhD, explore the potential for AI to transform drug discovery, charting a path towards more targeted precision therapeutics.

BIOAVAILABILITY & SOLUBILITY - Formulation Strategies for Tackling Poor Oral Bioavailability

Richard Johnson, PhD, says better characterization of NCEs in the early stages of development and identifying solubility issues early offers the opportunity to address poor bioavailability using formulation techniques that deliver enhanced drug exposure – reducing risk, conserving resources, and increasing the chances of clinical success.

CML ADVANCES - To Improve Upon a Miracle Drug: Overcoming Drug Resistance & Intolerance in CML

Ben Hohl, says while imatinib and other TKIs have undoubtedly positively impacted the lives of many people living with CML, thousands of patients are still looking for drugs that provide better efficacy, tolerability, and convenience.

COMBINATION PRODUCTS - Early Decisions to De-Risk the Transition to Combination Products

Dr. Mike Ulman says an important part of combination product development is compiling the regulatory submission. Without approval from regulatory bodies, products do not make it into regulated markets.

EXECUTIVE INVTERVIEW - Klotho Neurosciences: Focused on Neurodegenerative & Age-Related Disorders

Dr. Joseph Sinkule, Founder & CEO of Klotho Neurosciences, discusses the company, its therapies, the human Klotho gene, and longevity.

POLYMACROCYCLIC PEPTIDES - Engineering Structure for Function in Next Generation Therapeutics

Karsten Eastman, PhD, and Vahe Bandarian, PhD, believe the key challenge, and opportunity, is to sculpt peptide architecture so that shape and chemistry are presented to the target in the right place, at the right time, and for long enough to matter clinically.

TECHNOLOGY TRANSFER - Streamlining Biologics Technology Transfer Through Integrated Operational Models

Lalit Saxena explains how technology transfer in biologics manufacturing is an inherently complex process that requires the simultaneous control of multiple scientific, technical, and operational variables.

EXECUTIVE INTERVIEW - Lonza: Addressing Solubility Challenges in Early Stages of Drug Development

Adi Kaushal, Director and Technology Head, Bioavailability Enhancement, at Lonza, discusses solubility issues and Lonza’s approach to addressing these challenges in the early stages of drug development.

THERAPEUTIC FOCUS - Advancing Adjunctive Therapies for Depression & OCD Using Translational Pharmaceutics®

Jacob Jacobsen, PhD, Bret Berner, PhD, and Vanessa Zann, PhD, review a partnership with Evecxia Therapeutics to support the development of EVX-101, an investigational adjunctive drug for depression and obsessive-compulsive disorder (OCD) responding inadequately to first-line antidepressants.

RADIOLIGAND THERAPIES - Affibody Molecules: A Versatile Approach to Radiopharma

Fredrik Frejd reviews Affibody’s lead RLT candidate, ABY-271, currently being evaluated in a first-in-human clinical study in HER2 positive metastatic breast cancer.